The U.S. Food and Drug Administration (FDA) has opened applications for its PreCheck pilot program, an initiative designed to assist companies in building drug manufacturing facilities within the United States. The move is part of ongoing efforts to strengthen the domestic pharmaceutical supply chain.
The PreCheck program offers participating companies increased opportunities for direct communication with the FDA at key stages of facility construction. This includes guidance on site design, pre-production considerations, and support with the Chemistry, Manufacturing and Controls sections of regulatory submissions.
According to a statement from FDA Commissioner Marty Makary, “PreCheck is one of several powerful incentives that the agency is leveraging to redomicile drug production.” The selection process for participants will focus on alignment with national priorities such as innovation, the production of critical medicines needed domestically, and proposed production timelines. While applications are now open, the FDA has not announced how many facilities it expects to include or provided a detailed timeline for launching the program. However, PreCheck is scheduled to begin later this year.
Manufacturers and contract research organizations in the U.S. have expressed interest in PreCheck, anticipating that early engagement with regulators could help attract more clients from the pharmaceutical sector.
Christopher Shilling, chief regulatory officer at Forge Biologics, discussed industry challenges in an interview with BioSpace last month. He noted that “the FDA often doesn’t visit manufacturing plants until deep into the production process—and years after a facility has been constructed. Manufacturers often don’t have enough time to address the issues that arise during this time.”
Shilling added that timely feedback through PreCheck while facilities are still under construction could prevent costly design flaws and provide assurance to both manufacturers and their biopharma clients regarding regulatory compliance.
This pilot comes as major pharmaceutical firms increase investment in U.S.-based manufacturing operations. Recent announcements include AbbVie’s $100 billion plan over ten years—currently the largest such commitment—alongside Johnson & Johnson’s $55 billion pledge and AstraZeneca’s $50 billion investment.
